As official US policies increasingly incentivize domestic manufacturers to expand exports to the EU in order to influence the balance of trade, the topic of European regulations, market surveillance and technical standards has become more relevant than ever.
The regulatory philosophies of the United States and the European Union differ significantly. In the US, product safety and cybersecurity requirements are often sector-specific and frequently driven by liability exposure or contractual obligations. In the EU, by contrast, product compliance is embedded in a centralized legislative framework, enforced through mandatory CE marking and coordinated market surveillance across all Member States.
For the average US sales engineer or product manager working in industrial automation, navigating the European system of mandatory certifications, technical documentation, authorized representatives and harmonized standards can be daunting. In the US, such regulatory complexity is typically associated with consumer products. In the EU, however, it applies equally — and sometimes more strictly — to industrial machinery.
This article provides an overview of the European regulatory system, followed by a deeper analysis of industrial cybersecurity and the regulatory developments that will shape the next two years.
How Is Market Surveillance Implemented in the EU?
The European Union currently consists of 27 Member States. It operates as a common market, meaning that a product legally placed on the market in one Member State may circulate freely within the other 26.
For example, if a US manufacturer sells an industrial press to an Italian importer, Italian customs authorities will act as the first checkpoint for conformity assessment. Once the machine is lawfully placed on the EU market, it may be moved or resold within the EU without further customs controls.
Customs authorities across all Member States must apply the same European legislative acts. These acts take the form of Regulations or Directives. Both are mandatory and legally binding; however, they differ in how they are implemented.
There are currently around thirty EU legislative acts governing product safety, with at least ten directly relevant to industrial applications.
In theory, this harmonized framework facilitates market access. In practice, certain nuances remain.
Differences Between Member States
The first source of divergence lies in the nature of Directives. While Regulations apply uniformly and directly in all Member States, Directives must be transposed into national law. This process allows national legislators some discretion in implementation.
Two consequences follow. First, the timing of implementation may vary between countries. Second, national transposition may introduce technical differences — typically in the direction of stricter requirements.
A second source of divergence concerns the interaction between product legislation and national laws governing workplace safety, fire safety, and energy efficiency. These areas remain largely under national jurisdiction. As a result, Authorities Having Jurisdiction (AHJs) may interpret requirements differently, even when the underlying European directive is the same.
What Must Manufacturers Do Today to Export Machinery?
At present, any manufacturer exporting industrial machinery to the EU must primarily consider:
- Machinery Directive 2006/42/EC
- Low Voltage Directive 2014/35/EU
- Electromagnetic Compatibility Directive 2014/30/EU
These are typically covered under a single Declaration of Conformity accompanying the CE marking of an automated industrial machine.
Additional requirements may apply depending on the intended use:
- ATEX Directive 2014/34/EU (explosive atmospheres)
- MOCA Framework Regulation (EC) No 1935/2004 and GMP requirements (food-contact materials)
- Pressure Equipment Directive 2014/68/EU
- Gas Appliances Regulation (EU) 2016/426
Some of these acts apply only to specific components rather than to the entire machine.
Cybersecurity: Current Requirements and What Will Change
Historically, industrial cybersecurity has largely been treated as an asset owner responsibility. Standards and best practices were driven by industry rather than legislators.
This approach is changing.
The Impact of NIS2
Directive (EU) 2022/2555 (NIS2) establishes cybersecurity obligations for “essential” and “important” entities operating in sectors such as energy, transport, water, waste management, space, medical devices, automotive manufacturing, industrial machinery and the food supply chain.
Although NIS2 formally applies to operators rather than machinery manufacturers, in practice it indirectly affects them. Asset owners must assess cybersecurity risks across their facilities, including production lines. Since machinery manufacturers possess detailed knowledge of network architectures, firmware configurations and communication interfaces, they are increasingly required by contract to support NIS2 compliance.
However, NIS2 remains operator-focused.
The real regulatory transformation comes from product legislation.
The Machinery Regulation and the Cyber Resilience Act
Regulation (EU) 2023/1230 (the new Machinery Regulation), applicable from January 2027, introduces explicit requirements addressing risks related to software integrity and control systems reliability. These provisions aim at “cyber-safety”: ensuring that digital manipulation cannot create unsafe physical conditions.
In parallel, the Cyber Resilience Act (Regulation (EU) 2024/2847) establishes cybersecurity as a standalone product requirement.
The CRA applies to products with digital elements capable of direct or indirect network connectivity. For industrial automation manufacturers, this includes PLCs, industrial PCs, communication modules, embedded systems and, in many cases, complete machines.
Unlike NIS2, the CRA directly regulates manufacturers, importers and distributors.
Key obligations include:
- Cybersecurity risk assessment
- Secure-by-design and secure-by-default development
- Technical documentation covering cybersecurity
- Vulnerability management and coordinated disclosure
- Provision of security updates for a defined support period
- Ongoing post-market monitoring of vulnerabilities
This marks a fundamental shift. Traditional CE marking focuses on conformity at the moment of market entry. The CRA introduces lifecycle accountability: compliance becomes continuous.
Conclusion: A Structural Difference in Regulatory Philosophy
The emerging European framework — combining NIS2, the Machinery Regulation and the Cyber Resilience Act — reflects a distinctly preventive regulatory philosophy. Cybersecurity is not treated as a contractual enhancement or liability issue; it is defined as a public-interest obligation embedded in product law.
For US manufacturers seeking to expand into the European market, this shift has strategic implications. Cybersecurity must be integrated into product development, documentation, and post-market processes from the outset. It can no longer be addressed reactively through customer agreements.
Understanding this structural difference between the US and EU approaches will be essential not only for regulatory compliance, but also for maintaining competitiveness in a market where cybersecurity is becoming inseparable from product safety and market access.
Valeria Vergalli – Sales Manager Cybersecurity Division – AC&E www.ac-e.com
Valeria.Vergalli@ac-e.com